Pharmacokinetics, Safety, and Tolerance Study of Single Dose Administration of Risperidone ISM®

This study has been completed.
Sponsor:
Information provided by:
Rovi Pharmaceuticals Laboratories
ClinicalTrials.gov Identifier:
NCT01320410
First received: March 17, 2011
Last updated: April 30, 2014
Last verified: March 2011
  Purpose

The study will comprise two dosing periods in two different cohorts of healthy volunteers. The investigators will begin with a single dosage period I (1 injection of 25 mg of Risperidone for each subject); single dosage period II, different from the previous one (1 injection of 37.5 mg of Risperidone for each subject), in a second group of healthy volunteers different from the first group will not start until after a preliminary analysis has been made of the safety data and plasma concentration data are known for the formulation of prolonged release Risperidone using the ISM® technology.


Condition Intervention Phase
Healthy
Drug: ISM®
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Clinical Trial to Evaluate the Pharmacokinetics, Safety, and Tolerance of Single Dose Administration of a New Injectable Prolonged Release Formulation of Risperidone Using ISM® Technology in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Rovi Pharmaceuticals Laboratories:

Primary Outcome Measures:
  • The main objective of the study is to evaluate the pharmacokinetics, safety, and tolerability

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy volunteers of both sexes with a minimum age of 18 years and a maximum age of 50 years.
  2. Healthy female volunteers should have a negative pregnancy test and, if they are of childbearing age, should use at least 2 medically accepted contraceptive methods.
  3. Each volunteer must be capable of understanding enough to complete all tests and exams required in the protocol.
  4. Each volunteer must understand the nature of the study and sign an informed consent document.
  5. Vital signs (systolic and diastolic blood pressure, heart rate, and temperature) and ECG record within the normal range.
  6. The results of the laboratory tests (complete blood count and biochemistry) and ECG should fall within the normal reference ranges or show minor deviations that the investigator does not consider clinically relevant.
  7. The investigator must consider the volunteers suitable candidates for prolonged release intramuscular administration.
  8. Healthy volunteers must have a body mass index between 19 and 27 kg/m2, and weigh between 50 and 100 kg.
  9. Healthy volunteers may not have known cardiovascular disease, orthostatic hypotension, seizures, a family history of prolonged QT interval, bradycardia, electrolyte disturbances (hypokalemia, hypomagnesemia), or hyperprolactinemia.

Exclusion Criteria:

  1. Pregnant women, nursing women, and female volunteers who are not using effective contraceptive methods.
  2. Previous history of alcohol, drug, or substance abuse during the month prior to the selection. Average daily alcohol consumption exceeding 2 units (20 g/d). Smokers of more than 5-10 cigarettes per day in the 3 months prior to the start of the study.
  3. History of allergy, idiosyncrasy, hypersensitivity or severe adverse reactions to medications, or contraindications to treatment with Risperidone as recorded in the data sheet of the drug.
  4. Positive serology for hepatitis B or C, or for HIV.
  5. History or clinical evidence of cardiovascular disease, respiratory, renal, hepatic, endocrine, gastrointestinal, hematological, neurological, psychiatric, or other chronic diseases that may interfere with the objectives of the trial.
  6. Major consumer of stimulating beverages (> 5 cups of coffee, tea, cola drinks, or similar per day).
  7. Positive urine test for ethanol, cannabis, cocaine, amphetamines, benzodiazepines, or opiates.
  8. Baseline platelet number below 100,000/mm3 or serum potassium> 5.5 mEq / L.
  9. Having undergone surgery in the past 6 months.
  10. Plasma prolactin values outside the reference range (40 mcIU/ml to 530 mcIU/ml).
  11. Having participated in another clinical trial during the three months before the start of the study.
  12. Having donated blood within 4 weeks before the start of the study.
  13. Having taken medication regularly in the month prior to the start of the study or symptomatic medication in the week before the start of the study, except for oral contraceptives, vitamins, herbal remedies, or dietary supplements that, according to the Principal Investigator or co-workers designated by him/her, do not involve a risk for the subjects and do not interfere with the objectives of the study.
  14. Taking ASA and/or NSAIDs within 10 days before the start of the trial until the end of the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01320410     History of Changes
Other Study ID Numbers: ROV-RISP-2009-01
Study First Received: March 17, 2011
Last Updated: April 30, 2014
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on July 22, 2014